510(k) · Cleared
ClearedVelmeni for Dentists (V4D) Endo-Perio
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Velmeni, Inc. · MYN Analyzer, Medical Image
Cleared on May 11, 2026 as substantially equivalent to K240003 (Velmeni, Inc., 2024) after a 237-day review. Its family tree reaches back 4 generations to 1998.
- Decided
- May 11, 2026
- Review
- 237 days
- Class
- Class II
- Product code
- MYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to P980025 (1998). No later device cites it as a predicate yet.
- Root · 4 generations backP980025 Logicon Caries DetectorCarestream Dental, LLC · 1998 · Recalled
- 3 generations backK212519 Overjet Caries AssistOverjet, Inc. · 2022
- 2 generations backK222746 Overjet Caries AssistOverjet, Inc. · 2023
- 1 generation backK240003 Velmeni for Dentists (V4D)Velmeni, Inc. · 2024
- This deviceK252953 Velmeni for Dentists (V4D) Endo-PerioVelmeni, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | P980025 | Logicon Caries Detector | Carestream Dental, LLC | 1998 | 1 |
| −3 | K212519 | Overjet Caries Assist | Overjet, Inc. | 2022 | — |
| −2 | K222746 | Overjet Caries Assist | Overjet, Inc. | 2023 | — |
| −1 | K240003 | Velmeni for Dentists (V4D) | Velmeni, Inc. | 2024 | — |
| 0 (this device) | K252953 | Velmeni for Dentists (V4D) Endo-Perio | Velmeni, Inc. | 2026 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MYN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MYN device
- #1 K210365 Second Opinionscore 30.0 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K240003 | Velmeni for Dentists (V4D)Summary page 5…21CFR892.2070 Product Code: MYN Device Class: Class II Predicate Device(s) Predicate Device: Velmeni for Dentists (K240003) Reference Device: Overjet Charting Assist(K233590) Reference Device: Denti.AI Detect (K230144) Device Description VELMENI for D… | 2024 |
| † | K233590 | Overjet Charting Assist | 2024 |
| † | K210187 | Overjet Dental Assist | 2021 |
| † | K230144 | Denti.AI Detect | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 1 other device also cites its predicate K240003.
How does its category compare?
All MYN devicesMYN Analyzer, Medical Image: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · MYN
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MYN
210in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MYN
No recall names MYN since 2007.
Adverse event reports per year · MYN
2in 2025
MAUDE reports naming product code MYN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 6 | — | 0 | 0 |
| 2013 | 4 | — | 0 | 0 |
| 2014 | 3 | — | 0 | 0 |
| 2015 | 3 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 3 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 5 | 273 | 0 | 0 |
| 2023 | 10 | 229 | 0 | 0 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 14 | 210 | 0 | 2 |
| 2026 | 7 | 128 | 0 | — |
What is it indicated for?
VELMENI for DENTISTS (V4D) Endo-Perio is a concurrent-read, computer-assisted detection software intended to assist dentist in the clinical detection of tooth anatomy (enamel, dentine in crown, pulp, and root) , jaw anatomy (mental foramen, inferior alveolar canal, and maxillary sinus) , bone level(cementoenamel junction and crestal bone) and root canal treated tooth(RCT) in digital bitewing, periapical and panoramic radiographs of permanent teeth in…
Read the full statement (130 words)
VELMENI for DENTISTS (V4D) Endo-Perio is a concurrent-read, computer-assisted detection software intended to assist dentist in the clinical detection of tooth anatomy (enamel, dentine in crown, pulp, and root) , jaw anatomy (mental foramen, inferior alveolar canal, and maxillary sinus) , bone level(cementoenamel junction and crestal bone) and root canal treated tooth(RCT) in digital bitewing, periapical and panoramic radiographs of permanent teeth in patients 15 years of age or older. This device provides additional information for dentists in examining radiographs of patients’ teeth.
This device is not intended as a replacement for a complete examination by the dentist or their clinical judgment that considers other relevant information from the image, patient history, or actual in vivo clinical assessment. Final diagnoses and patient treatment plans are the responsibility of the dentist.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252953 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252953: Velmeni for Dentists (V4D) Endo-Perio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252953
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026